Prostate Cancer Clinical Trial
Fulvestrant in Hormone Refractory Prostate Cancer
Summary
The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA).
Full Description
The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA). In vitro studies have shown that fulvestrant downregulates androgen receptor (AR) in LNCaP cancer cell lines to a significant extent, thereby inhibiting growth of tumor cells. In addition, it is important to emphasize that fulvestrant has also been found to decrease growth of AR-negative prostate cancer cells. These observations provide the rational for using fulvestrant for the treatment of AIPC and HRPC.
Eligibility Criteria
Inclusion Criteria:
Must give signed written informed consent
Must be of age 18 years or older
Histologically confirmed adenocarcinoma of the prostate
Must be currently receiving LHRH agonists and have castrate levels of testosterone or have had an orchiectomy
Must have had rise in PSA despite anti-androgen withdrawal
Must exhibit two consecutive rises in PSA after the last hormonal manipulation
Minimum PSA > 5mg/dL
KPS > 80%
Up to one prior chemotherapy treatments allowed
Life expectancy of greater than 6 months
Exclusion Criteria:
Concomitant hormonal therapy other than an LHRH
Noncompliance
Platelets less than 100 x 10e9 /L
International normalization ratio (INR) greater than 1.6
Total bilirubin greater than 1.5 x ULRR
ALT or AST greater than 2.5 x ULRR if no demonstrable liver metastases or greater than 5.0 x ULRR in presence of liver metastases
History of bleeding diathesis (ie, disseminated intravascular coagulation [DIC], clotting factor deficiency)
History of long-term anticoagulant therapy (other than antiplatelet therapy)
History of hypersensitivity to active or inactive excipients of fulvestrant (ie, castor oil or Mannitol)
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There is 1 Location for this study
Stanford California, 94305, United States
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